[Federal Register Volume 64, Number 54 (Monday, March 22, 1999)]
[Notices]
[Pages 13801-13802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6882]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0462]


Agency Emergency Processing Request Under OMB Review; Collection; 
Survey of Manufacturers, Distributors, Repackagers, and Other Drug 
Distribution Facilities for Year 2000 Compliance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns a survey of manufacturers, distributors, 
repackagers, and other drug distribution facilities of Year 2000 
compliance. The list of the Year 2000 compliant facilities will be made 
available to the public via the World Wide Web. FDA is requesting OMB 
approval within 9 days of receipt of this submission.

DATES: Submit written comments on the collection of information by 
April 12, 1999.
ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Section 705(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 375(b)) permits the Secretary of Health and 
Human Services (the Secretary) to disseminate information regarding 
food, drugs, devices, and cosmetics in situations involving in the 
opinion of the Secretary imminent danger to health, or gross deception 
of the consumer. FDA has requested emergency processing of this 
proposed collection of information under section 3507(j) of the PRA (44 
U.S.C. 3507(j)) and 5 CFR 1320.13. FDA is requesting certain 
information, i.e., manufacturer, drug distribution, etc., immediately 
to allow health care facilities and others to assess their 
vulnerability to Year 2000 problems and to make corrective actions, if 
necessary, well in advance of January 1, 2000. The potential existence 
of Year 2000 problems in the drug industry, could pose potentially 
serious health and safety consequences. The use of normal clearance 
procedures would prolong the time needed to assess Year 2000 compliance 
by regulated industry.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Title: Survey of Drug Manufacturers, Distributors, and Repackagers, 
and Other Drug Distribution Facilities for Year 2000 Compliance

    Facilities will be asked to provide a status on their Year 2000 
readiness. They will also be asked if they have contingency plans. The 
survey will also ask if they have tested, verified, and certified their 
systems. The request will also ask for a single point of contact at the 
manufacturer to discuss information.
    The manufacturer will be able to provide facsimile, electronic, or 
paper copy of the information to FDA for inclusion in the web site data 
base. Government agencies, as well as health care facilities and the 
general public, will have access to the web site to be able to assess 
their vulnerability to Year 2000 problems and to take corrective 
actions, if necessary, in advance of January 1, 2000. The posting of 
information on compliant facilities is designed to provide health care 
facilities with a positive statement as to the status of compliant 
firms.
    Respondents: Manufacturers, distributors, repackagers, and others 
in the distribution chain of drug products.
    FDA estimates the burden of this collection as follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours
                                                     Response        Responses       Response
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4,000                                                   1           4,000              18          72,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 13802]]

    FDA mailing lists were used to estimate the number of firms who 
would be subject to this collection. FDA estimates that it will take 
firms an average of 18 hours to collect, prepare, and submit the 
requested information. These estimates include allowance for variance 
in the number to be reported by a manufacturer.

    Dated: March 15, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-6882 Filed 3-19-99; 8:45 am]
BILLING CODE 4160-01-F